MEDICATION RISKS

The purpose of this section is to disseminate the latest up-to-date news from medical and health-related journals regarding medications.  There are many benefits to the use of medications and some are vital, especially in life-threatening situations.  However, there are negative effects of medications that the public needs to be aware of so they and their doctors can make good informed decisions on their health care.  This page is updated regularly and stories are listed by the dates they are posted. 

       

March 7, 2008 VACCINE LED TO AUTISM-LIKE SYMPTOMS: FEDERAL GOV'T

The federal government has conceded in a vaccine court case that childhood vaccines worsened one girl's rare mitochondrial disorder leading to autism-like symptoms, according to Associated Press.  The government says the girl, who has oxidative phosphorylation disease, should be paid from a vaccine-injury fund.  However, the federal government is not admitting that vaccines cause autism.  We will see how this plays out over the next few years. 

    

 

     February 28, 2008 Fructose Consumption and Risk for Gout

Consumption of fructose from sugar-sweetened soft drinks and other sources increases risk for gout.

In recent decades, consumption of sugar-sweetened soft drinks (which contain high-fructose corn syrup) has increased dramatically in the U.S., and, at the same time, the prevalence and incidence of gout also have increased. Since fructose consumption rapidly increases blood uric-acid levels, might fructose consumption contribute to risk for gout?

Investigators prospectively obtained dietary information from 46,393 male health professionals who did not have histories of gout. After 12 years of follow-up, 755 men had developed gout. In analyses adjusted for age, body-mass index, diuretic use, renal insufficiency, consumption of alcohol and meat, and other variables, consumption of one sugar-sweetened soft drink daily significantly increased risk for developing gout compared with consumption of fewer than one soft drink monthly (relative risk, 1.45). Consumption of two or more soft drinks daily increased the relative risk to 1.85. Similarly, a significant dose-response relation was found between total fructose intake (i.e., soft drinks, fruit juices, fruits, and other sources of fructose) and risk for gout. Notably, consumption of diet soft drinks was not associated with gout.

Comment: Consuming sugar-sweetened soft drinks increases risk for obesity (Journal Watch Pediatrics and Adolescent Medicine May 23 2007) and type 2 diabetes mellitus (Journal Watch Women’s Health Oct 19 2004). Now, these data indicate that consuming sugar-sweetened soft drinks and other sources of fructose (e.g., fruit juice) also increases risk for gout. A growing body of evidence is adding credence to the adage "Don’t drink your calories."

February 28, 2008 CYCLOPHOSPHAMIDE FOR RHEUMATOID ARTHRITIS INCREASES RISK FOR CANCERS

People who take cyclophosphamide (Cytoxan or Neosar) are at higher risk for hematologic (blood) cancers especially lymphomas according to a large case control study in Archives of Internal Medicine.  More studies will have to be performed to confirm their findings. 

February 13, 2008 AND THEY THOUGHT I WAS CRAZY!!!

I have been saying for years that ALL medications, prescription and OTC, are dangerous.  There is no such thing as a "safe" medication.  How many are put on the market and promoted as safe to find 5-10 years later that they caused serious disease and even death as in this case.  Many of you love to take these cold medications when you are sick.  THINK TWICE AND EVEN 5 TIMES BEFORE YOU TAKE THEM AGAIN.  Want to substitute another drug? Be aware, chances are it is not safe either.  Life is full of choices...please make the correct ones!

Check out this story that was forwarded to me.  Then go to the link which is the FDA website:

I checked with our Medical insurance carrier to see if it was true and she confirmed that they have pulled several of these products off of the retail shelves because in rare cases it has been known to cause death.   I received this information from a friend whose mother recently passed away.  Apparently, this was caused by a medication that is deadly. Here are the details and I suggest you pass it on to your loved ones and others. 

Subject: Phenylpropanolamine (PPA)

 I would like to thank those of you who expressed condolences on the recent passing of my mother. She suffered a hemorrhagic stroke while she was driving home from my house on 7/30 and passed away on 8/3. My mother's stroke and passing was an enormous shock to my family because she did not have any symptoms or risk factors for a stroke. Just the week before she had gone to her doctor for a check up and received a clean bill of health. She did, however, develop a cold while she was visiting me and had taken Alka Seltzer Cold Plus for 3 days. Since her passing, we have learned that Alka Seltzer is one of the many cold medicines that contains Phenylpropanolamine (PPA) which can cause hemorrhagic stokes or cerebral bleeding even with the first use. I am forwarding a list of other medications that currently use PPA. These medicines are supposedly being recalled but my mother just purchased this medication less than two weeks ago. Pharmaceutical companies have known about this danger for years, we unfortunately, did not. 

I urge you to review the list of medicines with PPA and avoid these medications. All drugs containing PHENYLPROPANOLAMINE are dangerous. You may want to try calling the 800 number listed on most drug boxes and inquire about a REFUND. Please read this CAREFULLY. Also, please pass this on to everyone you know. STOP TAKING anything containing this ingredient. 

It has been linked to increased hemorrhagic stroke (bleeding in brain) among women ages 18-49 in the three days after starting use of medication. Problems were not found in men, but the FDA recommended that everyone (even children) seek alternative medicine. 

The following medications contain Phenylpropanolamine:

Acutrim Diet Gum Appetite Suppressant

Acutrim Plus Dietary Supplements

Acutrim Maximum Strength Appetite Control

Alka-Seltzer Plus Children's Cold Medicine Effervescent

Alka-Seltzer Plus Cold medicine (cherry or orange)

Alka-Seltzer Plus Cold Medicine Original

Alka-Seltzer Plus Cold & Cough Medicine Effervescent

Alka-Seltzer Plus Cold & Flu Medicine

Alka-Seltzer Plus Cold & Sinus Effervescent

Alka Seltzer Plus Night-Time Cold Medicine

BC Allergy Sinus Cold Powder

BC Sinus Cold Powder

Comtrex Flu Therapy & Fever Relief

Contac Day & Night 12-Hour Cold Capsules

Contac 12 Hour Caplets

Coricidin D Cold, Flu & Sinus

Dexatrim Caffeine Free

Dexatrim Extended Duration

Dexatrim Gelcaps

Dexatrim Vitamin C/Caffeine Free

Dimetapp Cold & Allergy Chewable Tablets

Dimetapp Cold & Cough Liqui-Gels

Dimetapp DM Cold & Cough Elixir

Dimetapp Elixir

Dimetapp 4 Hour Liquid Gels

Dimetapp 4 Hour Tablets

Dimetapp 12 Hour Extentabs Tablets

Naldecon DX Pediatric Drops

Permathene Mega-16

Robitussin CF

Tavist-D 12 Hour Relief of Sinus & Nasal Congestion

triaminic DM Cough Relief

triaminic Expectorant Chest & Head

triaminic Syrup !  Cold & Allergy

triaminic Triaminicol Cold & Cough

I just f ound out and called the 800# on the container for Triaminic

and they informed me that they are voluntarily recalling the following

medicines because of a certain ingredient that is causing strokes and

seizures in children:

Orange 3D Cold & Allergy Cherry (Pink)

 3D Cold & Cough Berry

 3D Cough Relief Yellow 3D Expectorant

 Do you take ANY of these??????

 They are asking you to call them at 800-548-3708 with the lot number

 on the box so they can send you postage for you to send it back to

 them, and they will also issue you a refund. If you know of anyone

 else with small children,

  To confirm these findings please take time to check the following:

  http://www.fda.gov/cder/drug/infopage/ppa/>

 http://www.fda.gov/cder/drug/infopage/ppa/

THIS IS JUST MORE EVIDENCE PROVING THAT THE CHIROPRACTIC PROFESSION HAS BEEN CORRECT FOR THE PAST 112 YEARS!

February 4, 2008 FDA: Chantix's Link to Neuropsychiatric Complications 'Increasingly Likely'

The FDA has issued a public health advisory on Chantix (varenicline), saying, "it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms."  The smoking-cessation drug, still under review by the agency, may have additional warnings added to its labeling.

The FDA announcement emphasized the following:

  • Before starting Chantix, patients should inform their clinicians about any history of psychiatric illness.
  • Providers, patients, and their families should monitor for mood and behavioral changes during and after Chantix treatment.

January 22, 2008 High Caffeine Intake During Pregnancy Increases Risk for Miscarriage

High caffeine consumption early in pregnancy increases risk for miscarriage, according to a study in the American Journal of Obstetrics & Gynecology.  Roughly 1000 women in the San Francisco area completed interviews at a median 71 days' gestation about the type and amount of caffeine they consumed. After adjusting for potential demographic and lifestyle confounders, as well as nausea and vomiting, researchers found that women who consumed 200 mg of caffeine or more (e.g., 10 oz. or more of coffee or five 12-oz. cans of caffeinated soft drinks) daily had more than double the risk for miscarriage by 20 weeks' gestation (hazard ratio, 2.23).

 

January 22, 2008 FDA: Clot Risk Higher in Ortho Evra Patch Users

The FDA has changed labeling for the Ortho Evra contraceptive transdermal patch to warn that users are at higher risk for venous thromboembolism (VTE) than those taking oral contraceptives.The label change was based on a new epidemiologic study that confirmed an earlier trial showing an approximate doubling of risk.

The FDA said women using Ortho Evra are exposed to about 60% more estrogen than those taking birth control pills containing 35 ug of estrogen. It said the patch is "a safe and effective method of contraception when used according to the labeling," which says that women concerned about VTE should discuss the risk with providers.

January 10, 2008 FDA CRITICIZES AVASTIN USE FOR BREAST CANCER

Genetech's drug Avastin did not help women with breast cancer live meaningfully longer and it caused significant side effects, including death.  Avastin is a successful drug for colon and lung cancer.  Moreover, it was already known that Avastin, like many cancer drugs, can cause serious side effects like cardiovascular problems and bowel perforations and even some deaths.  The issue in this case is whether the risks outweigh the benefits. 

January 10, 2008 REPORTS OF MEDICATION INJURIES DOUBLED

Study shows that  painkillers and immune system drugs account for most serious ills.  Reports of deaths or injuries to drug treatments more then doubled between 1998 and 2005 in the US.  This was reported in the Archives of Internal Medicine.  "This growing toll of serious injury shows that the existing system is not adequately protecting patients and underscores the importance of recent reports urging far-reaching legislation, policy and institutional changes."  The study found 467,809 such occurrences with annual reports growing from 34,966 at the start to 89,842 at the end.  The number of deaths jumped from 5519 to 15, 107. 

December 12, 2007 MORE ON DANGERS OF AVANDIA

Another study shows the risks of the diabetes drug, Avandia, which treats type 2 patients.  This study was published in Tuesday's Journal of the American Medical Association and it shows that Avandia users had a 60 percent increased risk of heart failure, a 40 percent increased risk of heart attacks and a 30 percent increased risk of death compared with patients taking other oral diabetes medicines. "Our study suggests that at least in this high-risk population, the harms of the drug may outweigh the benefits,” said the study’s lead author, Dr. Lorraine L. Lipscombe of the Institute for Clinical Evaluative Sciences in Toronto, an independent nonprofit group that evaluates treatments.  The study evaluated people over the age of 65 in the government controlled health care system of Ontario.  These findings mirror a study published in May in the New England Journal of Medicine. 

November 9, 2007 PAIN MEDS LINKED TO ELEVATED BLOOD PRESSURE

The Archives of Internal Medicine (a journal of the American Medical Association), issued a report that states that men who take commonly available pain medication may have an increased risk of high blood pressure as compared to men who do not take the medication.  Acetaminophen, ibuprofen and aspirin are among the most commonly used pain relievers.  All three medications may inhibit the effects of chemicals that relax the muscles surrounding the blood vessels, which would normally decrease blood pressure. Editor note:  For 30 years, the medical community has insisted that these medications were safe. 

November 9, 2007 COATED ASPIRIN DOESN'T REDUCE STOMACH RISK

It is common knowledge that aspirin causes stomach bleeding, ulcers and other stomach and intestinal problems.  Knowing this, many people take buffered or coated aspirin.  However the August 2007 publication of the Harvard Heart Letter notes that the above may have been a mistake.  Yet, contrary to the drug industry's marketing myth, studies show that coated aspirin has virtually the same effect on the stomach as plain, uncoated aspirin.    

November 6, 2007 BAYER REMOVES TRASYLOL

Bayer agreed to take Trasylol, a heart surgery drug to reduce bleeding, from the market after a Canadian study shows it increased fatalities.  Interestingly Dr. John J. Jenkins of the FDA said that they "could not identify a specific patient population where the benefits of using Trasylol outweighed the risks".  The NY Times reports that the study was the latest in a series of worrisome signs that Trasylol could be dangerous. Last year, a study published in The New England Journal of Medicine found that the drug increased the risks of kidney failure, heart attack and stroke. That research concluded that halting the drug’s use would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion a year in dialysis costs.

October 21, 2007 ASTHMA RESULTING FROM ANTIBIOTICS?

Children treated with antibiotics during the first year of life have an increased risk of developing asthma by age 7, according to a study by Ernst A. Koryrskyj and A. Becker published in Chest.  They found that children who received more then four courses of antibiotics before age 1 were at the highest risk. 

October 19, 2007 COLD MEDICATIONS CONTROVERSY

There has been a major controversial issue brewing that may result in either the removal of cold medications from the market, or at leas                                                                                                                                                   t the limitation of ingredients and restricting their use to children over 6 years of age.  Richard Abate of the Food and Drug Administration, said the array of products combining multiple medicines led some parents to overdose their children accidentally. He also advised that measuring devices commonly included with the products be standardized and made easier to understand. The panel, which the F.D.A. convened, began a two-day meeting Thursday to decide whether over-the-counter pediatric cough and cold medicines should continue to be sold and, if so, for whom. The session comes a week after major manufacturers agreed to withdraw more than a dozen such products labeled for use in infants and babies. If the panel agrees with Mr. Abate’s recommendations, more changes could be in the offing. Dr. Robert S. Daum, a panel member and pediatrician from the University of Chicago Medical Center, described pediatric cough and cold medicines as “a bewildering mess of complicated ingredients and combinations that do and don’t make sense.” He said he supported requiring single-ingredient products. Interestingly, studies over the past few years have demonstrated that the over 800 cold and cough medications have not only no effect, but are dangerous.  The NY Times reports that the American College of Chest Physicians recommends that these products not be used in children, and the American Academy of Pediatrics has recommended against their use in children under age 3 unless advised by a doctor.  Some panel members were incredulous that so many people could be so wrong for so long. “If these medicines are allegedly not effective or materially unsafe, how is the purchase of hundreds of millions of doses by parents to be explained?” asked Dr. George Goldstein, a pharmaceutical industry consultant and nonvoting panelist.

Various states have different recommendations on who should not be given cold medications.  Some say all children under 15; Others under 6 and still others under 2 years of age.  Editors note: Isn't it disconcerting that "they" can't decide who should be taking this medication?  Isn't it upsetting that cold medications have been around for decades, yet they are now considered worthless and even dangerous?  One other question to ponder.  If these over-the-counter medications are dangerous in children of unknown age, why are they not dangerous for adults?  Chiropractors have stated for over 100 years that drugs are not safe and should be taken with caution.  How can any doctor definitively state that a particular medication is in fact safe?

October 17, 2007 MORE ANTIBIOTIC PROBLEMS

A new study published today in the Journal of American Medical Association demonstrates that 19,000 people died in 2005 directly as a result of infections from methicillin-resistent staphylococcus aureus. If these estimates are correct, more people have died from MRSA than from Aids, Parkinsons, emphysema or homiside each year. Researchers estimated that 94,360 developed an invasive infection from the pathogen and nearly one in five died from it.  The study points out that it is not always possible to definitively determine that MRSA is the cause in all cases or merely  accelerates it.  The prevalence of invasive MRSA — when the bacteria has not merely colonized on the skin, but has attacked a normally sterile part of the body, like the organs — is greater, Dr. Bancroft wrote, than the combined rates for other conditions caused by invasive bacteria, including bloodstream infections, meningitis and flesh-eating disease.  The bacteria can be brought unknowingly into hospitals and nursing homes by patients who show no symptoms, and can be transmitted by contact as casual as the brush of a doctor’s lab coat. Highly opportunistic, they can enter the bloodstream through incisions and wounds and then quickly overwhelm a weakened immune system. Editor note: Staphylococcus aureaus never used to be problematic in society.  They commonly reside on skin and rarely infected humans.  With the overuse and misuse of antibiotics, the number of staph aureas infections have risen significantly over the past 20 years. 

October 1, 2007 BRAINWASHING?

Let's first define brainwashing.  It is the art of subtly convincing to believe something that is not true and/or change his opinion to what you would like him to believe.  This is done through constant influence over a certain period of time.  So who is doing this?  The pharmaceutical industry.  According to a recent study in the New England Journal of Medicine, the total amount spent on pharmaceutical promotion was $29.9 Billion in 2005, up from only $11.4 billion in 1996.  In excess of $25 billion was spent to influence physicians and hospitals to prescribe certain drugs, while about $4 billion was spent on direct to consumer advertising.  $30 billion is more then the annual budget expenditures in every state but 10 in the US.  With that kind of money, they can buy anyone or anything they want.  Don't you think you could influence just about any person in the world?  A recent study in Pediatrics proves this point.  In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians released a clinical practice guideline on the management of acute otitis media or ear infections.  The guidleine included the endorsement of a wait and see attitude, rather than prescribing antibiotics.  The year the guideline was released, 88% of medical physicians believed this recommendation was reasonable. That number slipped to 83.6% in 2006.  When asked if they were using the recommended wait and see option, only 15% of physicians answered in the affirmative.  When asked why they didn't use the wait and see option, 83.5% stated that it was because the parents of the children preferred the antibiotic route.  Marketing accomplished successfully!  There is more....Another recent study published in Chest revealed that the incidence of asthma increased in 7 year olds, if they were given antibiotics in their first year.   So now the drug companies have convinced the public to give antibiotics to its children with an ear infection and then they get to sell them asthma medication for the rest of their lives!  They have convinced 83.5& of the physicians to recommend the antibiotics.  Now they have to target the other 16.5%!!  Chiropractic is the leading non-drug healthcare profession in the US.  It is our responsibility to the public to give both sides of the story. 

September 28, 2007 VERY SCARY!  MORE FDA PROBLEMS

The FDA does very little to ensure the safety of people taking part in clinical trials.  The inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials have no idea how many clinical trials are being conducted, audited less than 1% of the test sites, and when inspectors did appear, usually showed up after the trials have been completed.  According to the NY Times, there are about 350,000 testing sites and only 200 auditors.  Even when the auditors found serious problems with the trials, Washington has minimized them 68% of the time.  (Editor note: Oh, yes---medications are safe!)

September 10, 2007 STUDY SHOWS MEDICATION INJURIES HAVE DOUBLED

According to Thomas Moore of the Institute for Safe Medication Practices in Huntingdon Valley, Pa., findings came from a look at serious adverse drug events as reported to the U.S. Food and Drug Administration from 1998 through 2005.  This was published in the Archives of Internal Medicine.  Death and injuries from drug treatments doubled from 1998 to 2005. 

A “serious adverse drug event” is one that causes death, birth defects, disability, puts someone in a hospital or was life-threatening.  The FDA is supposed to monitor these occurrences directly or from the drug makers. 

The study found 467,809 such occurrences during the period studied, with annual reports growing from 34,966 at the start to 89,842 at the end. The number of deaths due to drugs jumped from 5,519 to 15,107 during the study period.

According to the researchers, “The overall relative increase was four times faster than the growth in total U.S. outpatient prescriptions, which grew in the same period from 2.7 billion to 3.8 billion."

The researchers estimated that 25% of the increase results from a growing population and more intensive use of drug therapy.  An additional 15 percent of the increase appears to involve newer drugs such as interferons, which help the body’s immune system attack viruses, bacteria and other invaders.

 

August 15, 2007 FDA ISSUES WARNING ABOUT OVER-THE-COUNTER COUGH AND COLD MEDICATIONS

The FDA announced that in October the Non-prescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use in children.  Questions have been raised about the safety of these products and whether the benefits justify any potential risks from the use of these products in children, especially under the age of 2.  Some reports of serious adverse events associated with the use of these products appear to be the result of giving too much of these medicines to children.  Parents are being warned to not give these products to children under age 2 without the consent of their doctors.  They are also being told that they only treat the symptoms and do not cure the cold.  Children get better with time. 

Editor note: My question is that if they are not safe in children under 2, how safe can they be in children who are 3 or 4?  How about 12 or 15?  How about adults?  Yes, their bodies are less mature, however if they are found risky for one group, they have to result in negative effects in the other groups as well. 

August 14, 2007 XOLAIR WARNING (Asthma Medication)

The FDA issued a black box warning in July for Xolair. 

FDA ALERT [2/2007, updated 7/2007]:  This Alert highlights important revisions to the full prescribing information for Xolair.  The updated full prescribing information for Xolair (July 2007) includes a new Boxed WARNING, updated WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS--Post-marketing Spontaneous Reports.  A New Medication Guide [PDF] about the risk of anaphylaxis following administration of Xolair is to be distributed with each dose of Xolair. These revisions address the risk of anaphylaxis following treatment with Xolair.  The implications of this new labeling for healthcare professionals who administer Xolair are summarized below.  Xolair is approved to treat adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. 

July 27, 2007 DANGERS OF AVANDIA

The According to federal drug reviewer report, the results and conclusions of a study published in the New England Journal of Medicine has been confirmed.  Patients who take Avandia, a popular diabetes medicine, face an increased risk of heart attacks while those who take Actos, a similar drug, do not.  The drugs increase the body's sensitivity to insulin.  Yet GlaxoSmithKline, the maker of Avandia, continues to insist the drug is perfectly safe.  In 1999, GlaxoSmithKline was supposedly accused of attempting to intimidate a doctor for questioning the safety of Avandia.  According to the NY Times, the FDA has been criticized for its handling of Avandia. 

In February 2006, Dr. Rosemary Johann-Liang, a drug safety supervisor, recommended that the labels of both Avandia and Actos receive the agency’s most severe safety warning — called a “black box” — for their tendencies to worsen the risks of heart failure, a problem distinct from the heart attack risks seen only in Avandia.

Her recommendation was ignored and she was punished for it, Dr. Johann-Liang said in an interview last month. In June, the agency announced that it had decided to follow Dr. Johann-Liang’s advice. By then, she had tendered her resignation. 

This is just another example of unsafe drugs finding their way into the marketplace.  The public is just guinea pigs.  When enough people die, the FDA steps in and removes the drugs from the market.

July 13, 2007 Cough and Cold Medications Cause 3 Infant Deaths

The US Food and Drug Administration has asked all health care professionals to warn their patients of the risks of administering cough and cold medications to infants younger that two years of age.  According the medical examiners who conducted the autopsies of the three infants, cough and cold medications were the cause of their deaths.  The cases were reported in the Centers for Disease Control and Prevention's Mortality and Morbidity Weekly Report.

July 13, 2007 Med/Watch Sends Out Alert On Rota Teq Vaccine

The FDA has issued a public health notification following 28 reports of intussusception, which is a prolapse of one part of the intestines into another part.  Medwatch, which is the FDA's safety and adverse event reporting program, noted in the alert that they did not know for certain that these cases were caused by the vaccine, but they did advise parents that they should see their doctors if after the vaccination, the child had stomach pain, vomiting, diarrhea, blood in the stool or change in their bowel movements.  The 28 cases occurred after each of the 3 doses of the vaccine regimen and almost half occurred within 1-21 days of vaccination.  Although no deaths occurred, 16 infants required intestinal surgery. 

July 13, 2007 Acne Drug Seems to Raise the Risk of Potential Heart and Liver Problems

According to the Associated Press on August 22, 2006, Accutane, the powerful acne drug already known to cause birth defects, seems to raise the risk of potential heart and liver problems more then doctors had expected, according to a new study.  The findings came from lab tests on 13,772 patients taking the popular drug.  Among patients with normal lab tests before they started taking the drug, 31 percent developed high cholesterol levels and 11 percent had abnormal liver tests.  Here is where the balance of benefits vs. risk is important. 

July 13, 2007 Report Finds a Heavy Toll From Medication Errors

According to the NY Times on July 21, 2006, medication errors harm 1.5 million people and kill several thousand each year in the US, costing the nation at least $3.5 billion annually, in a report put out by the Institute of Medicine.  Drug errors are so widespread that hospital patients should expect to suffer one every day then remain hospitalized, although error rates vary by hospital and most do not lead to injury, the report concluded.  This is their fourth report.  The first, "To Err is Human", was released in 1999 and caused a sensation when it estimated that medical errors led to as many as 98,000 deaths each year, more than was caused by highway accidents and breast cancer combined.  Negative effects are bad enough, but combined with human error cause inexcusable deaths. 

July 13, 2007 FDA Finds That Bayer Failed to Reveal Drug Risk Study

In a NY Times article on September 30, 2006, it was reported that Bayer failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke.  This was announced by the FDA.  Bayer scientists appeared at a public meeting called by the FDA on September 21 to discuss the possibility that the drug, Trasylol, might have serious risks, but they did not mention the study or its worrisome results.  Preliminary results of the study demonstrate "that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes," the FDA advisory said.  However, the FDA did not change its recommendation about the use of the drug.  It restated prior warnings that the drug should only be used on patients whose potential benefits exceeded the risks. 

July 13, 2007 FDA Had Questioned Another Bayer Drug in 2004

FDA had questioned if Bayer was forthcoming about safety concerns with its cholesterol-lowering drug, Baycol.  The allegation was that the company knew but was slow to inform the government that its drug was riskier than comparable drugs.  According to the Journal News on November 27, 2004, Bayer internal records indicated that by May 28, 1998, three months after the drug went on the market, people who took the drug with gemfibrozil, another cholesterol lowering drug, had elevated levels of an enzyme that accompanies muscle injury or had developed a rare muscle-wasting disorder.  Bayer did not warn doctors and patients not to take the two drugs together until December 1999.  Bayer scientists, according to the article, knew in late 1999 and early 2000 that using Baycol alone "substantially increased the risk" of people getting a rare muscle-wasting condition, compared to a rival drug, but they did not immediately notify physicians and patients.  The JAMA article alleged that before the agency was aware of the data, the company knew the drug was more dangerous than others.  Is the public just a group of guinea pigs who represent billions of dollars of revenue to the pharmaceutical companies?

July 13, 2007 The Vioxx Debacle

On September 30, 2004, Merck voluntarily withdrew Vioxx from the market after an   internal study was stopped due to an increased risk of severe cardiovascular side effects among those taking Vioxx.  Vioxx was approved by the Food and Drug Administration (FDA) in 1999 as a treatment for osteoarthritis, severe back or joint pain in adults and for moderate to severe menstrual pain.

Vioxx was viewed as a breakthrough in pain relieving technology, as it was found to reduce or even eliminate intestinal irritation, stomach ulcers and other gastrointestinal side effects associated with traditional, "Aspirin type" painkillers.

Heavily marketed to consumers, Vioxx was also promoted by Merck sales representatives to physicians as a pain relieving medicine of choice. As a result, Vioxx was sold to more than 92 million patients in the U.S. since its approval in 1999. The majority of Vioxx users ended up taking the drug over extended periods of time due to the chronic nature of their ailments, such as arthritis, osteoarthritis and rheumatoid arthritis.

It is estimated that at the time of the recall, as many as 2 million patients were taking Vioxx worldwide. Recent reports indicate that the cardiovascular side effects of Vioxx could have caused as many as 100,000 hospitalizations, 27,785 heart attacks and strokes, and possibly as many as 10,000 to 15,000 deaths in the U.S.

There is evidence that Merck knew about the cardiovascular side effects of Vioxx as early as 2000, four years before the manufacturer pulled the popular pain reliever from the market.

Yet there were many patients who were upset that the drug was taken off the market.  All they were concerned about was that the drug helped to relieve their pain.  They were not concerned that it might cause them to have heart attacks and strokes!  (Until they suffer a heart attack or stroke and survived!)

July 13, 2007 Bextra Taken Off the Market

The Food and Drug Administration has asked Pfizer to remove the anti-inflammatory drug Bextra from pharmacy shelves. The painkiller is the latest inhibitor of the enzyme known as cox-2 that has been shown to increase risks to heart, stomach and skin. The FDA named 18 other prescription and over-the-counter medicines that may pose a danger.  Chiropractic is becoming the treatment of choice for chronic pain as a result of the harmful effects of the popular anti-inflammatory drugs.  Chiropractic is perfectly safe, effective and should be included in everyone's health regimen.

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